NCT07225075招募中不适用
Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER)
Balt USA3 个研究点 分布在 2 个国家目标入组 250 人开始时间: 2026年2月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- Proportion of participants with complete occlusion of the treated IA based on the Raymond-Roy I classification without significant parent artery stenosis (>50%), as evaluated by an independent Core Lab, without retreatment of the target aneurysm
研究概览
简要总结
The PIONEER Study is a pivotal, multi-center, prospective, single-arm study designed to evaluate the safety and efficacy of the Silk Vista Baby (SVB) Flow Diverter for the treatment of unruptured aneurysms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22 to ≤ 80 years old
- •Participant has a single target unruptured intracranial aneurysm (IA) originating from a parent vessel of 1.5 mm to 3.4mm in diameter located at or distal to the ICA terminus or in SVB-amenable anterior or posterior anatomy
- •Participant has a target saccular or fusiform IA with an aneurysm neck ≥ 4mm or a dome to neck ratio <2
- •Participant has a target IA that is ≤ 12 mm
- •Participant meets one or more risk factors for IA rupture, such as age (≤70); hypertension; cigarette smoking; use of sympathomimetic drugs; Japanese or Finnish ancestry; history of prior aneurysmal subarachnoid hemorrhage (aSAH); familial intracranial aneurysms or SAH; clinical or radiological mass effect; reduced quality of life due to fear of rupture; IA size, location, and morphology (yielding 1 point or greater score per UIATS scale); documented growth of IA on serial imaging; presence of multiple IAs; and presence of concurrent pathology
- •Participant has pre-procedure (obtained up to 14 days prior to the procedure day) PRU value between 60-200
- •Participant or a legally authorized representative (LAR) provides written informed consent using the IRB/REB-approved consent form and agrees to comply with protocol follow-up and requirements
排除标准
- •Target aneurysm is unsuitable for flow diverter treatment
- •Subject requires more than one flow diverter for target aneurysm treatment
- •Has vessel characteristics, such as severe tortuosity, stenosis, atherosclerotic disease, or morphology that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device
- •Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
- •Has a medical contraindication to study or procedure-related antiplatelet/anticoagulation medications (e.g., aspirin, clopidogrel/Plavix, ticagrelor, Prasugrel, Gp IIb/IIIa inhibitors, heparin, etc.), local or general anesthesia, or life-threatening allergy to contrast dye
- •Has a known severe allergy to nickel, titanium or platinum
- •Modified Rankin Score (mRS) assessment is ≥ 3 at screening or pre-procedure mRS could not be assessed
- •The health of the participant or the validity of the study outcomes (e.g., high risk of neurologic events, worsening of clinical condition in the last 30 days) may be compromised by the participant's enrollment
- •Subarachnoid hemorrhage occurred within 30 days prior to enrollment
- •Intracranial parenchymal hemorrhage occurred within 60 days prior to enrollment
- •Major surgery (including previous intracranial implant) occurred within previous 30 days or is planned in the next 120 days after treatment date
- •Has more than one IA that requires treatment within 120 days of treatment date
- •Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 12 weeks prior to treatment date
- •Requires adjunctive coiling during SVB procedure
- •Chronic anticoagulation therapy is ongoing or known coagulopathy exists
- •Has other known serious concurrent medical conditions such as active bacterial infection, heart disease (including atrial fibrillation, pacemaker, recent myocardial infarction [< 12 weeks], symptomatic congestive heart failure, or carotid stenosis), kidney failure (e.g., >2.0mg/dl serum creatinine) or any other non-neurological disease-related acute life threatening illness to be treated in this trial, pulmonary disease, uncontrolled diabetes, progressive neurologic disorders, cancer requiring active treatment (e.g., chemotherapy, etc.) or on palliative care, vasculitis, high risk of ischemic stroke or recent stroke (within 30 days)
- •Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)
- •Unable to complete study follow-up due to dementia or psychiatric disorder, substance abuse, or history of noncompliance with medical advice
- •Women who are pregnant or nursing at the time of enrollment or women who wish to become pregnant during the length of study participation
- •Presence of intracranial mass (tumor, except meningioma that doesn't require surgery for 1 year) or non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
- •Participation in any other investigational study which can influence collection of valid data under this study
研究组 & 干预措施
Silk Vista Baby (SVB) Flow Diverter
Experimental
Participants meeting eligibility criteria will undergo endovascular treatment of a single unruptured intracranial aneurysm using the SVB Flow Diverter.
干预措施: Silk Vista Baby (SVB) Flow Diverter (Device)
结局指标
主要结局
Proportion of participants with complete occlusion of the treated IA based on the Raymond-Roy I classification without significant parent artery stenosis (>50%), as evaluated by an independent Core Lab, without retreatment of the target aneurysm
时间窗: 1 year post procedure
次要结局
- Complete occlusion of the treated aneurysm using the Raymond-Roy scale without significant parent artery stenosis (>50%), as adjudicated by an independent Core Lab, without retreatment of target IA(180 days and 2 years post-procedure)
- Complete occlusion of the treated aneurysm using the O'Kelly Marotta scale without significant parent artery stenosis (>50%), as adjudicated by an independent Core Lab, without retreatment of the target IA(180 days, 1 year, and 2 years post-procedure)
- Clinically acceptable occlusion of the treated aneurysm using the Raymond-Roy scale without significant parent artery stenosis (>50%) as adjudicated by an independent Core Lab, without retreatment of the target IA(Within 180 days, 1 year, and 2 years post procedure)
- Unplanned alternative treatment of the target IA(Within 1 year post procedure)
- Device deployment success rate(Index procedure)
- Device migration rate(180 days, 1 year, and 2 years post procedure)
- Evolution of occlusion between post-procedure and timepoints listed under timeframe, as adjudicated by an independent Core Lab(1 year and 2 years post procedure)
- Occurrence of parent artery occlusion(1 year and 2 years post procedure)
- Occurrence of >50% In-Stent Stenosis at the target IA(1 year and 2 years post procedure)
研究者
研究点 (3)
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